Process Engineer - Packaging at Eli Lilly and Company

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

The Packaging Engineer provides process and packaging engineering support to the Plainfield, IN and Enfield, CT Distribution Centers along with routinely interfacing with Global Packaging / Technology engineering resources and process teams. The role seeks to develop, qualify, and optimize shipping container systems for all existing and new pharmaceutical products. The position also assists in the development of new package technologies (materials, methods, or equipment) for Lilly products. Other responsibilities include capital project implementation, commissioning, qualification, and GMP improvement planning/execution.

Responsibilities:

Regulatory Compliance: Partner with Quality Assurance to assure that all building-related equipment and packaging systems meet corporate standards, including, but not limited to drawing management, version management, commissioning, qualification, validation, change management, and system maintenance.

Design/Improve Cold Chain/Temperature Sensitive Packaging/Shipping Technologies

• Identify and champion packaging system improvements that improve shipping economics (lower cost, equal or better performance)

• Identify packaging to improve product protection, cost and compliance

• Stay abreast of industry trends and explore new materials, methods, and improved packaging processes

• Develop and implement a packaging strategy for continuous quality improvement of domestic product shipping

• Participate in industry groups / forums that address quality issues related to packaging/shipping pharmaceuticals.

• Provide technical leadership to Distribution, Global Logistics LT as well as Domestic/International Lilly Affiliates.

• Provide technical guidance (consulting) to Lilly affiliates with respect to temperature-controlled packaging.

• Develop domestic and international ambient temperature profiles for Refrigerated and CRT product shipment package development.

• Conduct distribution testing for package configurations

• Coordinate harmonization/standardization efforts with domestic and international Lilly affiliates

• Provide Industry technical leadership for continuous improvement efforts.

Benchmark with other Pharma companies to understand synergies within temperature-controlled shipping. Shipping Package Qualification

• Engage with upstream marketing, development, and manufacturing to influence packaging design

• Develop specifications and drawings • Interface with vendors, procurement, PMQC

• Optimize current shipping processes and procedures

• Develop and implement shipping lane studies for current finished products

• Develop and implement a robust temperature-monitoring program for carrier and small packages.

Packaging Stability and Regulatory

• Design package screening studies

• Recommend package for temperature control, finished product stability

• Apply packaging laws and guidelines

• Apply packaging specifications, qualification process, product/package stability, and data evaluation

• Apply and follow laws, regulations, and guidance applicable to pharmaceutical industry

Marketed Product Support

• Support new product launches at NALO sites: Plainfield, IN; Enfield, CT and 3rd party affiliates

• Support post-approval changes and improvement projects

• Support packaging aspects of the Materials Quality Plan for outbound shipping.

Safety

• Model safe behaviors within daily work.

• Provide support to the operational areas to address any safety concerns.

• Execute projects and activities according to HSE requirements.

Data Integrity

• Responsible for ensuring data integrity and good documentation practices while performing job tasks

Basic Qualifications/ Requirements:

• BS in Engineering (Packaging, Industrial, Mechanical) or other engineering discipline with applicable work experience.

• Work experience within an operation / manufacturing environment.

Additional Skills/Preferences:

• Knowledge of cGMP, SAP, TrackWise (QMS).

• Product development experience.

• Specialization in Packaging preferred.

• Knowledge of technology advances in packaging.

• Pharmaceutical or Medical Device Industry experience.

• Understanding of temperature mapping processes, devices, and software.

• Experience with Change Management, Deviation Management, Periodic Reviews, Commissioning & Qualification, Routine Data Monitoring / Reporting.

• Root cause analysis and problem solving (CAPA).

• Ability to apply fundamental engineering principles to process understanding, problem solving and process improvement.

• Experience with the principles of lean manufacturing to drive continuous improvement and operational excellence.

• Strong verbal and written communications skills. This role must effectively communicate with Management, Operations, Maintenance, Quality, IT, HSE, and outside regulatory inspectors. Must provide regular updates, conduct meetings, and produce presentations.

• Strong self-management and organizational skills.

Additional Information:

• Engineer will be provided a cell phone and is expected to provide off-hours support for critical equipment issues or special projects.

• Some domestic and international travel may be necessary.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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